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Legislative Update

House Energy and Commerce Committee Passes Strict Drug Safety Bill Without the Most Onerous Marketing Provisions;

Representative Stark Proposes Tax Penalties for Drug Advertising

June 21, 2007-- Today moderate House Democrats teamed up with Republicans on the Energy and Commerce Committee to pass a significant drug safety bill that omits many of the onerous provisions that would have suppressed professional and consumer marketing. The compromise bill largely tracks the Senate bill passed last month, including the marketing amendments spearheaded by Senator Pat Roberts (R-KS).

Representatives Ed Towns (D-NY) and Steve Buyer (R-IN) sponsored the marketing compromises earlier this week during the Health Subcommittee debate that deleted provisions giving FDA authority to review all marketing plans, pre-clear all consumer advertising, and ban consumer advertising for new drugs. The Towns-Buyer amendment also gives FDA new authority to exact fines from companies that repeatedly violate FDA marketing rules.

However, the fight is not over yet. Also today, Representative Pete Stark (D-CA) introduced a sweeping measure in the House Ways and Means Committee that keeps the debate over drug marketing alive this session of Congress. The new Stark bill would deny the tax deductibility for most drug advertising and in effect reintroduces many of the anti-DTC measures rejected today in the House Commerce Committee. Industry lobbyists believe that the new Stark measure is unconstitutional and faces other legislative challenges, but refuse to call it dead because of the current Congressional uneasiness about drug advertising. View Stark press release (PDF).

Because the Commerce Committee PDUFA Reauthorization bill contains “must pass” spending authority for the FDA, a House floor vote is likely in the next few weeks. The House and Senate versions will then be reconciled by a Senate-House Conference Committee, before the bill is sent to the President for signature.

The bill contains several amendments to the Food, Drug and Cosmetic Act governing the FDA, including a new PDUFA measure that enables the drug industry to pay fees for DTC advertising reviews, but does not mandate such reviews.

The Commerce Committee bill also gives FDA significant new power to respond to drug safety issues by imposing Risk Evaluation and Management Plans (REMS) on drugs with serious safety concerns. However, the compromise version neither forces the FDA to impose REMS on all drugs nor authorizes the other sweeping marketing restrictions proposed by Representatives Frank Pallone (D-NJ), Henry Waxman (D-CA) and Edward Markey (D-MA). The compromise version also eliminates a “pre-emption” provision favored by liberal Democrats that would have given new power to states and private litigants to impose additional limits on drug marketing.

In the Subcommittee vote, the nine Democrats voting for the compromise were Towns, Bart Gordon (TN), Tammy Baldwin (WI), Eliot Engel (NY), Mike Ross (AR), Darlene Hooley (OR), Anthony Weiner (NY), Jim Matheson (UT), and Energy and Commerce Committee Chairman John Dingell (MI). All Republicans supported the compromise measure.

Today’s vote was achieved through a major industry effort: advertisers, agencies, and media. Industry lobbyists reported that much of the credit should be given to the agency and publisher messages to Commerce Committee members, especially those in the New York and Chicago areas. Lobbyists also noted that although several members dislike consumer advertising, they were persuaded that the marketing provisions violated the First Amendment.

If you haven’’t contacted a Committee member and would like to, visit our website Web site: >www.cohealthcom.orgcom< for details.

Constitutionality Primer

Advertising Coalition Letter to House Representatives

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